Tibolone is approved for medical use by CDSCO India for the treatment of complaints resulting from the natural or surgical menopause and prevention of osteoporosis.

Tibolone is a hormone replacement therapy used in women to treat postmenopausal symptoms and prevent osteoporosis. Postmenopause occurs when a woman has not had a period of 12 months or more. In postmenopausal women, a decrease in estrogen levels may cause symptoms such as hot flashes (hot neck, face, and chest). Osteoporosis is a bone disease that is common in postmenopausal women and weakens and thins bones by reducing bone density.

Tibolone is available as a 2.5mg tablet in different brands to be used under physician direction. Your doctor will decide the most suitable dosage for your case according to your age and physical circumstances.

Tibolone may cause serious side effects like high blood pressure, jaundice, and migraine-type headaches, as well as common side effects including stomach and breast pain, vaginal issues (bleeding, itching, irritation, discharge, yeast infection), abnormal hair growth, weight gain, postmenopausal hemorrhage, pelvic pain, cervical dysplasia, endometrial hyperplasia, and abnormal cervical smears. Not everyone experiences these side effects.

Inform your doctor before taking Tibolone if you experience allergic (hypersensitive) to medicine. Notice your doctor if you have pulmonary embolism (blood clot in lungs), history of heart disease  (angina, myocardial infarction, stroke, or transient ischemic Attack) Before starting treatment with this medication, let your physician know if you have any liver, kidney, or uterine conditions. Inform your doctor if you have high blood pressure, diabetes, migraine or severe headaches, epilepsy, asthma, otosclerosis (a problem with hearing), or ever had breast cancer, vaginal bleeding, and thrombosis (blood clot in a vein). It is not recommended if you are a pregnant or breastfeeding woman.

When considering Tibolone, certain precautions should be taken. It is unsafe for use during pregnancy and breastfeeding, as it may harm the unborn baby or pass into breast milk. Patients with a history of liver disease should use Tibolone cautiously and may require dose adjustments; consult your doctor in such cases. The safety of Tibolone in patients with lung diseases is not well-established, so it's important to inform your doctor if you have any lung conditions before starting the medication. Additionally, avoid alcohol consumption while taking Tibolone, as it could increase the risk of breast cancer.

It is suggested to inform your doctor if you have a history of allergic reactions to Tibolone to avoid life-threatening complications. Tell your doctor before the treatment commencement if you are pregnant or having liver, kidney, or uterine problems. Your doctor may prescribe you to regularly check your breasts for any changes in the nipple, dimpling of the skin, or lumps, and undergo regular breast screening and cervical smear tests while on treatment with this medicine.

1. KD Tripathi, Essentials of Medical Pharmacology, Estrogens, Progestins and Contraceptives, 7th Edition, 2013, 306-311.
2. Mercury Pharmaceuticals Limited., Electronic Medicines Compendium (EMC), [Revised on September 2020] [Accessed on 20th Sept 2023] https://www.medicines.org.uk/emc/files/pil.4429.pdf
3. Steven R Cummings et al; The effects of tibolone in older postmenopausal women; published on Aug 2014; [Accessed on 20th Sept 2023]; https://pubmed.ncbi.nlm.nih.gov/18703472/

The drug information on this page is not a substitute for medical advice. It is meant for educational purposes only. For further details, consult your doctor about your medical condition to know if you can receive this treatment.